Administrative Measures for the Registration of Medical Devices
Administrative Measures for the Registration of Medical Devices
Administrative Measures for the Registration of Medical Devices
Order of the China Food and Drug Administration No.4
July 30, 2014
The Administrative Measures for the Registration of Medical Devices, which were deliberated and adopted at the executive meeting of the China Food and Drug Administration on June 27, 2014, are hereby promulgated for implementation as of October 1, 2014.
Minister Zhang Yong
Administrative Measures for the Registration of Medical Devices
Chapter I General Provisions
Article 1 The Administrative Measures for the Registration of Medical Devices (hereinafter referred to as the "Measures") are formulated pursuant to the Regulations on the Supervision and Administration over Medical Devices, with a view to regulating the administration over the registration and record-filing of medical devices, and ensuring the safety and effectiveness of medical devices.
Article 2 Sale or use of Medical devices within the territory of the People's Republic of China shall be subject to application for registration or record-filing in accordance with the Measures.
Article 3 Registration of medical devices refers to the process in which food and drug administrations, according to the applications submitted by applicants for the registration of medical devices and in accordance with the statutory procedures, conduct a systematic evaluation of the safety and effectiveness research and the results thereof of the medical devices to be made available on the market so as to decide whether or not to approve such registration applications.
Record-filing of medical devices refers to the process in which applicants for the record-filing of medical devices submit record-filing materials to the food and drug administrations, which shall archive the same for future reference.
Article 4 Registration and record-filing of medical devices shall be conducted in an open, fair and impartial manner.
Article 5 Class-I medical devices shall be managed by record-filing, while Class-II and Class-III medical devices shall be managed by registration.
Applicants for the record-filing of Class-I domestic medical devices shall submit record-filing materials to the food and drug administrations at the level of cities with districts.
Class-II domestic medical devices shall be reviewed by food and drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government which shall issue a medical device registration certificate upon approval after review.
Class-III domestic medical devices shall be reviewed by the China Food and Drug Administration (hereinafter referred to as the "CFDA") which shall issue a medical device registration certificate upon approval after review.
Applicants for the record-filing of Class-I imported medical devices shall submit record-filing materials to the CFDA.
Class-II and Class-III imported medical devices shall be reviewed by the CFDA which shall issue the Medical Device Registration Certificate upon approval after review.
The provisions governing the registration and record-filing of imported medical devices apply mutatis mutandis to the registration and record-filing of medical devices from Hong Kong, Macao and Taiwan region.
Article 6 When the applicants for registration and record-filing of medical devices launch medical device products on the market in their own names, they shall bear legal liabilities for such products.
Article 7 Food and drug administrations shall promptly publish the information on the registration and record-filing of medical devices pursuant to the law. Applicants may inquire about the examination and approval progress and the results thereof, and the public may consult the examination and approval results.
Article 8 The State encourages the research and innovation of medical devices, conducts special examination and approval of innovative medical devices, and promote the popularization and application of new technologies for medical devices so as to push forward the development of the medical device industry.
Chapter II Basic Requirements
Article 9 Applicants for the registration and record-filing of medical devices shall establish quality management systems related to product research and development and manufacturing, and maintain the effective operation thereof.
In the case of an application for registering a domestic medical device subject to examination and approval under the special examination and approval procedures applicable to innovative medical devices, where the sample of the domestic medical device is to be entrusted to other enterprises for manufacturing, only medical device manufacturers with the corresponding production scope shall be entrusted. In the case of an application for registering a domestic medical device not subject to examination and approval under the special examination and approval procedures applicable to innovative medical devices, the sample of the domestic medical device shall not be entrusted to any other enterprises for manufacturing.
Article 10 Persons handling the registration or record-filing matters relating to medical devices shall have appropriate expertise, and be familiar with the laws, regulations, rules and technical requirements on the administration over the registration or record-filing of medical devices.
Article 11 To apply for registration or go through record-filing, an applicant for registration or record-filing shall follow the basic requirements for the safety and effectiveness of medical devices, and ensure that the research and development process is standardized and that all data are authentic, complete and traceable.
Article 12 Materials submitted for registration application or record-filing shall be made in Chinese. Chinese translations of materials in foreign languages shall be accompanied by the original materials. When literature not openly published is cited, proofs of the licensing for use granted by the owners of such materials shall be provided.
Applicants for registration and record-filing shall be responsible for the authenticity of the materials submitted by them.
Article 13 An imported medical device for which a registration or record-filing application is submitted shall have been approved for sale on the market in the country (region) of the registration place or manufacturing address of the applicant for registration or record-filing.
Where the said product is not managed as a medical device in the country (region) of the registration place or manufacturing address of the applicant for registration or record-filing, the said applicant shall provide the relevant supporting documents, including the proof that the product has been approved for sale on the market in the country (region) of the applicant's registration place or manufacturing address.
Article 14 An overseas applicant for registration or record-filing shall designate its representative office established within the territory of China or an enterprise qualified as a legal person within the territory of China as its agent to render cooperation during the relevant work.
In addition to handling the registration or record-filing matters relating to a medical device, such an agent shall also assume the following responsibilities:
1. to communicate with the corresponding food and drug administration and the overseas applicant for registration or record-filing;
2. to convey the relevant regulations and technical requirements to the overseas applicant for registration or record-filing in a faithful and accurate manner;
3. to collect information on the adverse incidents of the medical device after it is made available on the market, feed back the same to the applicant for the overseas registration or record-filing, and report the same to the corresponding food and drug administration;
4. to coordinate the recall of the medical device after it is made available on the market, and report the relevant information to the corresponding food and drug administration; and
5. to bear other joint and several liabilities concerning product quality and after-sale services.
Chapter III Product Technical Requirements and Registration Testing
Article 15 Applicants for registration or record-filing shall prepare product technical requirements for the medical devices to be registered or record-filed. Applicants for the record-filing of Class-I medical devices shall submit their product technical requirements to the food and drug administrations when going through record-filing. The product technical requirements for Class-II and Class-III medical devices shall be verified and approved by the food and drug administrations upon approval of registration.
The product technical requirements of a medical device mainly cover the performance indicators and testing methods of the finished medical device product. Specifically, performance indicators refer to the functionality and safety indicators of a finished medical device product that can be objectively determined, as well as other indicators related to quality control.
Medical devices made available on the Chinese market shall meet product technical requirements that have been verified and approved upon registration or that have been filed for record.
Article 16 Registration testing is required for applications for the registration of Class-II and Class-III medical devices.
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